tamsulosin + tadalafil

AD-116A is an incrementally modified drug (IMD) developed by Addpharma, Inc., consisting of a fixed-dose combination (FDC) of tamsulosin and tadalafil. Tamsulosin is a selective alpha-1 adrenergic receptor antagonist that targets the ADRA1A, ADRA1B, and ADRA1D subtypes, leading to the relaxation of smooth muscle in the prostate and bladder neck, which improves urine flow in patients with benign prostatic hyperplasia (BPH). Tadalafil is a potent and selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), which enhances the effects of nitric oxide to relax smooth muscle in the prostate and bladder. This combination therapy is designed to provide synergistic relief for lower urinary tract symptoms (LUTS) associated with BPH. AD-116A is a specific formulation being evaluated in clinical trials, including bioequivalence studies comparing it to previous iterations like AD-1161, to optimize its pharmacokinetic profile.